Trends in Specialty Drug Approvals & Management: A Look at 2021-2024
Specialty drug approvals have shown a consistent upward trend in the past decade. Technological advancements in drug discovery and development have led to treatments for complex and rare diseases previously lacking therapeutic options, as evidenced by FDA approval trends.
Trends in FDA Drug Approvals 2021-2024
FDA Drug Approvals Traditional vs. Specialty 2021-2024
Specialty Drug Approvals
Between 2021 and 2023, over 80% of FDA-approved drugs were specialty drugs, indicating a continued upward trajectory. This surge was primarily fueled by advancements in the autoimmune and oncology sectors.(1)
Contact Axum for complete list of specialty drug approvals.
FDA Drug Approvals Pharmacy vs. Medical Benefit 2021-2024
Across Pharmacy & Medical Benefit
Roughly 40% of specialty drugs approved from 2021 to 2023 fall under the medical benefit category, emphasizing the vital necessity for a unified specialty drug management approach covering both pharmacy and medical benefits.
Employers and plan sponsors should prioritize the establishment of a thorough specialty drug management strategy within the medical benefit as they due with the pharmacy benefit. This proactive approach not only substantially improves patient care but also presents significant opportunities for cost savings. Recognizing and promptly acting upon these opportunities is essential for plan sponsors to maximize specialty drug management strategies.
FDA Approved Specialty Drugs Requiring Monitoring: September 2023-Febuary 2024
Clinical Management
An analysis of 29 drugs approved between September 2023 and February 2024 revealed that an estimated 90% of them were classified as Specialty Drugs. Among these specialty drugs, 50% or more require clinical monitoring before and during therapy, highlighting the importance of meticulous patient management to optimize outcomes.
Contact Axum for complete list of specialty drug approvals.
Specialty Drug Cost
While the cost per dose is a more accurate measure, examining unit prices provides useful insights. Over 40% of specialty drugs approved from 2021 to 2023 had a unit price of $1000 or more, with over 15% exceeding $5000.(3) This contributes to the growth in specialty drug spend, which accounted for 55% of net spending as of March 2022, up from 28% in 2011.(1)
Trends in Specialty Drug Management: Challenges and Goals for Payors
As these trends in specialty drug approvals continue, their utilization is projected to increase as a proportion of total prescription drug usage, thereby expanding their portion of overall prescription expenditures. This underscores the growing importance of specialty drugs for plan sponsors, making them a top priority.
A 2023 report outlined the top challenges and goals for payors in specialty drug management, including financial management, integration across pharmacy and medical benefits, and clinical management.(2)
Financial Management: Challenges include accessing reliable data on total cost of care and managing affordability of specialty drug cost-sharing. Goals include managing overall specialty trend, total cost of care, and reducing patient out-of-pocket costs.
Managing across Pharmacy and Medical Benefit: Challenges involve achieving cost parity and accessing integrated data, with goals including managing site of care.
Clinical Management: Challenges include optimizing formularies and utilization management programs, with goals focusing on reducing inappropriate utilization and improving adherence.
Other Goals: Additional goals include increasing transparency and improving patient satisfaction.
Axum Rx: Revolutionizing Specialty Drug Management
Axum Rx offers the Eureka Specialty Drug Management Ecosystem, addressing key challenges and goals in specialty drug management. Designed by pharmacists, Eureka provides transparent, patient-centered, outcome-focused management covering both pharmacy and medical benefits, with modules for clinical, financial, and drug use optimization. Powered by SaaS and AI, Axum's solution is comprehensive and reliable, prioritizing patient needs and delivering results for plan sponsors.
Contact Us to Learn More About Axum’s Solutions
Contributions by: Nicholas Hodgen, Pharm.D. Candidate 2024 & Cheleen Park, Pharm.D. Candidate 2024
References:
Biggs S., Long D. Insights Into the 2023 U.S. Pharmaceutical Market. IQUVIA. 2023
Pharmaceutical Strategies Group. 2023 Trends in Specialty Drug Benefits Report. Dallas, TX: PSG.
AWP unit price collected from Micromedex, Red Book.
FDA drug approval data from https://www.fda.gov